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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027341
Receipt No. R000031242
Scientific Title Evaluation Study of Vision-related Essential Skills with WAVES(Wide-range Assessment of Vison-related Essential Skills) in the Children Suspected Higher-order Visual Dysfunction.
Date of disclosure of the study information 2017/07/01
Last modified on 2017/05/15

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Basic information
Public title Evaluation Study of Vision-related Essential Skills with WAVES(Wide-range Assessment of Vison-related Essential Skills) in the Children Suspected Higher-order Visual Dysfunction.
Acronym Evaluation Study of Vison-related Essential Skills.
Scientific Title Evaluation Study of Vision-related Essential Skills with WAVES(Wide-range Assessment of Vison-related Essential Skills) in the Children Suspected Higher-order Visual Dysfunction.
Scientific Title:Acronym Evaluation Study of Vison-related Essential Skills.
Region
Japan

Condition
Condition Psychogenic visually impairment, learning disability, pervasive developmental disorder
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the vision-related essential skills in the children suspected of the psychogenic visually impairment or learning disability or pervasive developmental disorder without eye diseases other than refractive error.
Basic objectives2 Others
Basic objectives -Others Quantification of the function to understand the information from eyes (spatial perception/cognition, form perception/ cognition, visual memory), and evaluation of the weak points in the individuals.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quantification of the function to understand the information from eyes (spatial perception/cognition, form perception/ cognition, visual memory), and comparison of the value with the children of the same age.
Key secondary outcomes Quantification of the function to understand the information from eyes (spatial perception/cognition, form perception/ cognition, visual memory), and evaluation of the weak points in the individuals.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Intervention period is only inspection time around 1 hour.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
6 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Children suspected of the psychogenic visually impairment, learning disability, or pervasive developmental disorder.
Key exclusion criteria Children with eye diseases other than refractive error.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chizu Touge
Organization Faculty of Medicine, Tottori University
Division name Division of Ophthalmology
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori 683-8504, JAPAN
TEL 0859-38-6617
Email mihokan@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chizu Touge
Organization Faculty of Medicine, Tottori University
Division name Division of Ophthalmology
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori 683-8504, JAPAN
TEL 0859-38-6617
Homepage URL
Email mihokan@med.tottori-u.ac.jp

Sponsor
Institute Division of Ophthalmology.
Faculty of Medicine, Tottori University.
Institute
Department

Funding Source
Organization Division of Ophthalmology.
Faculty of Medicine, Tottori University.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 鳥取大学医学部附属病院、野島病院 / Faculty of Medicine, Tottori University, Nojima hospital

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 15 Day
Last modified on
2017 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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